drugset / Trial / NCT00932529

Use, Effects and Side-effects of Second-generation Antipsychotics in a Naturalistic Setting

NCT00932529

Phase 4 Completed 226 enrolled University of Bergen
RandomizedParallel-groupSingle-blindTreatment

Summary

Despite different pharmacological properties, the scientific evidence is inconclusive regarding which of the first-line second generation antipsychotics (SGAs) should be preferred for the individual patient suffering from psychosis. The limitations of the evidence base may be related to the highly selected samples, short duration, and rigid experimental designs of most randomized clinical trials of efficacy. Moreover a high proportion of the clinical trials are drug company sponsored which could introduce funding bias. The purpose of this non-commercially funded study is to investigate whether effectiveness differences exist among the first-line SGAs olanzapine, quetiapine, risperidone, and ziprasidone when the drugs are used in a representative clinical setting. Eligible patients are those admitted to hospital for acute psychosis and candidates for oral antipsychotic treatment. The investigators hypothesise that in the naturalistic setting of every-day clinical practice and in a diverse sample representative of most patients admitted for symptoms of acute psychosis, differential effectiveness among the SGAs could be disclosed when the patients are followed for up to 2 years. This could deliver valuable information regarding which SGA should be the starting antipsychotic drug in order to facilitate the most beneficial outcome.

Timeline

Start
2003-02
Primary completion
2010-01
Completion
2010-01

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Olanzapine Small molecule 2.5 mg Oral
Comparator Olanzapine Small molecule 20 mg Oral
Comparator Quetiapine Small molecule 25 mg Oral
Comparator Quetiapine Small molecule 800 mg Oral
Comparator Risperidone Other / unclassified 1 mg Oral
Comparator Risperidone Other / unclassified 6 mg Oral
Comparator Ziprasidone Small molecule 20 mg Oral
Comparator Ziprasidone Small molecule 160 mg Oral

Indications